Posterior spinal arthroplasty-development of a new posteriorly inserted artificial disc and an artificial facet joint

ABSTRACT

Lumbar disc and facet joint replacement prosthesis are provided. The lumbar disc prosthesis includes first member having a vertebral disc contact surface and a recessed portion on an opposing surface thereof and a second member having a vertebral disc contact surface and a protruding portion on an opposing surface thereof. The protruding portion of the second member engages the recessed portion of the first member in use. The first and second members are provided with at least a middle section and two end sections. The recessed and protruding portions are provided in the middle section of the respective members and each end section has a narrowing taper. The facet joint prosthesis includes a first member for attachment to a first posterior lumbar disc and a second member for attachment to a second posterior lumbar disc. At least a part of the first member is telescopically mounted in at least a part of the second member.

REFERENCE TO PENDING APPLICATIONS

This application claims priority to Great Britain Patent Application No.0422963.9 filed Oct. 15, 2004.

FIELD OF THE INVENTION

This invention relates to devices and surgical methods for the treatmentof various types of lumbar spine pathologies. It is specificallydirected to the different types of degenerative pathologies in thelumbar spine. It deals with the development of an artificial facetjoint, and an artificial lumbar disc replacement that is specificallydesigned to be inserted from a posterior approach to the spine.

BACKGROUND OF THE INVENTION

Back pain affects 40% of the population. Up to 20% of the populationvisit their family doctor requesting help with their back problem. Up to30% of patients continue to complain of significant back pain at oneyear following the onset of their symptoms.

Although the majority of patients have minor sprains or strains whichare self limiting, a significant number of patients go on to developsevere chronic mechanical lower back pain which is caused byinflammatory changes in the lumbar disc associated with degeneration.

Another group of patients with degenerative spine disease go on todevelop degenerative spondylolisthesis and spinal stenosis. This is anarrowing of the spinal canal caused primarily by degenerative changesin the facet joint, combined with a loss of normal disc height andbuckling of the ligamentum flavum.

Degeneration occurs in a spinal segment. The spinal segment consists ofthe lumbar disc anteriorly and two facet joints posteriorly. This istherefore called a three joint complex. Degenerative changes in the disccan lead to changes in the facet joint and vice versa. In patients withsignificant lumbar disc degeneration, the facet joints are also usuallydegenerate.

Pain occurs from all components of the three joint complex, includingthe facet joints and the disc. The facet joint is in fact a synovialjoint and suffers from the problems that are known to affect othersynovial joints in the body like the hip and the knee. The facet jointparticularly contributes to degenerate spondylolisthesis and commonlyoccurs at levels where the facet joints are sagittally orientated, forexample at the L4/5 level.

After failing all the conservative treatments available, a minority ofpatients with back pain or leg pain will go on to require surgicalintervention. For patients with predominantly lower back pain who have adegenerative lumbar disc, some surgeon's consider the solution lies inremoving the pain generator which is the disc and restoring normalloading across the disc by doing an inter-body stabilisation procedure.

The two types of inter-body stabilisation procedure currently availableare an artificial disc replacement performed anteriorly and inter-bodyfusions performed anteriorly and/or posteriorly. These inter-bodystabilisation procedures are often combined with decompression of thespinal canal and the nerve roots if there is nerve root impingement.

As far as inter-body fusions are concerned, there are two basicstrategies that surgeons adopt. The first is to perform an anteriorinter-body fusion combined with posterior stabilisation externally ofthe spinal canal. Anterior inter-body fusion on its own is stillquestioned because it does not provide a posterior tension band. Analternative strategy is a posterior lumbar inter-body fusion, where theentire inter-body fusion procedure is performed from behind and it iscombined with neural decompression as well as removal of thedegenerative facet joints. Posterior lumbar inter-body fusion alsoprovides a posterior tension band. This strategy therefore deals withall three joint components which can generate possible pain at the disclevel, including the lumbar disc, the neural structures and the facetjoints.

When it comes to lumbar disc arthroplasty procedures, these areperformed via an anterior lumbar approach. The disc is removed and anartificial lumbar disc is inserted into the space. This removes the paingenerator and allows normal loading across the disc, as well as allowingsome movement at this level. The advantage of this is to reduce thestrains on the disc above and therefore reduce the chances of adjacentsegment degeneration. Several studies have shown that adjacent segmentdegeneration can occur above a fused segment because of the increasedloads being transmitted to this level.

One of the disadvantages of anterior lumbar arthroplasty is that thefacet joints at this level continue to move and also continue to act asa pain generator. In addition, if there is any neural impingement, thesesymptoms can continue. The other disadvantage of anterior lumbararthroplasty is that the majority of spine surgeons are not familiarwith the anterior approach, and although complications are uncommon,they can be life and limb threatening when they do occur.

There is therefore a concern among researchers and the surgicalcommunity, that long term results of anterior lumbar disc arthroplastymay be compromised by progressive degeneration of the facet joint at thesame level. In addition, after lumbar disc arthroplasty, severalpatients continue to complain of facet joint pain because of increasedloads being placed on the facet joint as a result of the surgicalprocedure.

At present there is no posterior lumbar arthroplasty procedureavailable. It is therefore an aim of the present invention to provide anartificial lumbar disc that can be inserted posteriorly, therebydelivering the advantages of approaching the spine posteriorly andremoving the disadvantages associated with approaching the spineanteriorly.

It is a further aim of the present invention to provide a facet jointreplacement prosthesis.

It is a yet further aim of the present invention to provide a lumbarprosthetic system that deals with the painful disc, the neuralimpingement and the painful facet joints by providing a combination of alumbar disc prosthesis and a facet joint prosthesis as a single unit.

BRIEF SUMMARY OF THE INVENTION

According to a first aspect of the present invention there is provided alumbar disc prosthesis, said lumbar disc prosthesis including a pair ofdisc members, the first member of said disc pair having a vertebralendplate contact surface and a recessed portion on an opposing surfacethereof, the second member of said disc pair having a vertebral endplatecontact surface and a protruding portion on an opposing surface thereof,the protruding portion of the second member engaging with the recessedportion of the first member in use, and wherein the spinal discprosthesis includes a further pair of disc members, said further pair ofdisc members also including first and second members.

Preferably the disc pairs are mirror images of each other.

Thus, the present invention provides a lumbar disc prosthesis having twodisc member pairs and thus two separate articulating portions, onearticulating portion on each pair of disc members. The disc member pairsare each independently inserted into the disc space on either side ofthe dural sac in use through the trans-foraminal or posterior routebilaterally and are provided a spaced distance apart in use to allowaccommodation in accordance with the anatomy of the lateral aspect ofthe disc space. Thus, the disc prosthesis can be inserted through theposterior route whilst taking into account the neural anatomyposteriorly.

The lumbar disc prosthesis of the present invention can be inserted atall levels between L2 and the sacrum, typically depending on the levelof expertise of the operating surgeon.

Preferably the first members of each disc pair are provided in the leftand right areas of the disc space respectively in use. The secondmembers of each disc pair are also provided in the left and right areasof the disc space respectively in use. Thus, each pair of membersconstitutes a left and right lumbar disc prosthesis.

Preferably the recessed portion of the first member is substantiallycurved and the curvature of the medial part of said recessed portion isasymmetrical to the curvature of the lateral part of said recessedportion.

The purpose of this asymmetry in the medial-lateral plane is to allow“capture” of the protruding portion of the second member. such that whentwo pairs of disc prostheses are placed in the patient, the twovertebrae can move from side to side as well as anteriorly andposteriorly.

Preferably the lateral part of the recess has curvature corresponding toan arc of a circle which has a radius greater that of an arc of a circlecorresponding to the curvature of the medial part of the recessedportion. Further preferably the radius of the lateral part is at leasttwice as big as the radius of the medial part.

Preferably an anterior part of the recessed portion is substantiallysymmetrical to a posterior part of the recessed portion.

The protrusion portion of the second member is typically of differentshape and/or dimensions to the recessed portion of the first member.Thus, the protrusion portion is asymmetrical or forms an asymmetricalfit with the recessed portion.

Preferably the protrusion portion is substantially dome shaped and makescontact with only a part of the recessed portion when assembled.Preferably the recessed portion is substantially an inversed dome shape.

The protrusion portion is typically symmetrical in theanterior-posterior plane and in the medial to lateral plane. Thecurvature in the medial to lateral plane can be the same or different tothat in the anterior to posterior plane.

Preferably the inner or opposing surfaces of each of the first andsecond disc members are provided with at least three sections; a middlesection and at least two end sections, the recessed and protrudingportions being provided in the middle section of the respective discmembers.

Preferably the thickness or depth of the first disc member is lessadjacent the middle section or recessed portion compared to the two endsections thereof.

The middle and end sections of each disc member are typically arrangedtransversally along the length thereof, i.e. the boundaries of adjacentsections are provided between the medial to lateral sides of the discmembers.

Preferably one or both ends of the first and second disc members have anarrowing taper (i.e. the prosthesis as a whole has a narrowing taper).This narrowing taper is as a result of the outer or vertebral end platecontact surface of said first and/or second disc member being providedat an acute angle with respect to the horizontal at one or both ends.These angled surfaces are preferably substantially planar in form. Forexample, the outer or vertebral end plate contact surface of the firstdisc member slopes downwardly towards the ends of the disc member and/orthe outer or vertebral end plate contact surface of the second discmember slopes upwardly towards the ends of the disc member. Thenarrowing taper of the prosthesis allows easy insertion of theprosthesis in the disc space via a posterior route.

In one embodiment, the narrowing taper is provided at an anterior end ofthe prosthesis. Thus, the outer surfaces or vertebral endplate contactsurfaces of the disc member(s) slope towards the opposing surfacesthereof at the anterior end of the disc member(s). This provides a “leadin” feature which increases the ease with which the front of theprosthesis can be inserted via a posterior route into the disc space.

In one embodiment, a narrowing taper is provided at the posterior end ofthe prosthesis. Thus, the outer surfaces or vertebral endplate contactsurfaces of the disc member(s) slope towards the opposing surfacesthereof at the posterior end of the disc member(s). The posterior angledsurface allows the prosthesis in the neutral position to be placed suchthat the vertebral end plates are in lordosis.

The posterior end of the prosthesis typically slopes or tapers in anopposite direction to the anterior end.

Preferably the anterior end slope is substantially smaller than theposterior end slope.

Preferably one or both end sections of the inner or opposing surfaces ofsaid first and/or second members are provided at an acute angle to thehorizontal. For example, the inner end section surface of said firstmember can slope downwardly towards one or both ends of said member. Theinner end section surface of said second member can slope downwardlytowards the one or both ends of said member.

Further preferably the outer and inner surfaces of said second discmember form a narrowing taper towards one or both ends of said discmember.

Further preferably the outer and inner surface of said first disc memberform a narrowing taper adjacent an end of said disc member in whichattachment screws are to be located therethrough.

The geometry of the middle and end sections of the first and second discmembers allow contact to be made between the recessed and protrusionportions thereof and for a gap to be formed adjacent the end sections ofthe disc members when the prosthesis is in a neutral position. When theprosthesis is in extension or flexion (i.e. the upper or first discmember moves towards the posterior or anterior end of the lower orsecond disc member), the gap between the end sections at the oppositeend increases, thereby causing the annulus in which the disc prosthesisis located to tighten. Due to the geometry of the planar slopes withinthe prosthesis the annulus will tighten not only posteriorly in flexionbut laterally as well.

Preferably the vertebral endplate contact surface of the first and/orsecond members of each disc pair is provided with attachment means forallowing attachment of the disc member to an adjacent disc in use.

The attachment means can include one or more apertures for the locationof screws and/or any other suitable attachment device therewith, one ormore tapered members or fins and/or any other conventional attachmentapparatus.

The first and second members of each pair typically correspond to upperand lower disc members. The superior surface of the lower disc memberhas a protrusion thereon and the inferior surface of the upper discmember has a captive recess or socket thereon.

Preferably the recessed portion has two sloped surfaces associatedtherewith, typically corresponding to the end sections thereof, onesurface leading anteriorly to the edge of the inferior surface and onesurface leading posteriorly to the edge of the inferior surface. Thesesloping surfaces can be planar or can be slightly concave in form.

The lumbar disc prosthesis can be used in conjunction with a facet jointprosthesis also provided posteriorly to provide a system which can worktogether as a single unit to replace the painful disc, overcomes neuralimpingement and painful facet joints.

Preferably the facet joint prosthesis typically includes a first memberfor attachment to a first vertebra of a corresponding disc and a secondmember for attachment to a second vertebra of a corresponding disc inuse, and wherein at least a part of said first member is telescopicallymounted in at least a part of said second member in use.

Preferably the first and second members are elongate members and theprovision of one telescopically mounted in the other allows the distancebetween parts of the first and second members to be increased and/ordecreased as required.

The first vertebra is typically an upper vertebra and the secondvertebra is typically a lower vertebra.

The facet joint prosthesis allows replacement of existing facet jointsto be undertaken at all lumbar levels from T12 to the sacrum.

The interconnecting first and second members are formed such that theycan articulate to allow flexion-extension, small degrees of rotation andside to side flexion.

Preferably securing means are provided for insertion of the first andsecond members into each of the vertebral bodies above and below thedisc between which the facet joint prosthesis is to be located. Thefirst and second members can then be secured to said securing means. Aplurality of first and second members can be attached to the securingmeans if required to form a stack, thereby allowing facet jointreplacement at multiple levels within the spine.

The securing means can include any suitable type of surgical securingdevice, such as a pedicle screw.

According to a second aspect of the present invention there is provideda lumbar disc prosthesis, said lumbar disc prosthesis including a pairof disc members, the first member of said disc pair having a vertebralendplate contact surface and a recessed portion on an opposing surfacethereof, the second member of said disc pair having a vertebral endplatecontact surface and a protruding portion on an opposing surface thereof,the protruding portion of the second member engaging with the recessedportion of the first member in use, and wherein the recessed portion ofthe first member is substantially curved and the curvature of the medialpart of said recessed portion is asymmetrical to the curvature of thelateral part of said recessed portion.

According to a third aspect of the present invention there is provided afacet joint prosthesis, said prosthesis including a first member forattachment to a first lumbar disc in use and a second member forattachment to a second lumbar disc in use, and wherein at least a partof said first member is telescopically mounted in at least a part ofsaid second member in use.

The facet joint prosthesis can be used alone or in combination with thelumbar disc prosthesis of the present invention or with any other lumbardisc prosthesis. The facet joint replacement procedure of the presentinvention alone will have a role in the treatment of patients withspinal stenosis and adjacent level disc disease, where some stability isrequired at the disc level without fusing a particular disc segment. Thefacet prosthesis can partially constraining certain degrees of motion.

According to further independent aspects of the present invention thereis provided a prosthesis system including a lumbar disc prosthesis and afacet joint prosthesis as hereinbefore described; a first or upper discmember for inclusion in a lumbar disc prosthesis pair; a second or lowerdisc member for inclusion in a lumbar disc prosthesis; a method ofinsertion of a lumbar disc prosthesis in a patient via a posteriorroute; and a method of insertion of a facet joint replacement prosthesisin a patient via a posterior route.

Thus, the present invention overcomes the problems and disadvantagesassociated with current disc replacement strategies. It has all thebenefits associated with posterior lumbar inter-body fusion surgery, butat the same time it allows movement at that level and reduces the strainon adjacent discs and the risks of adjacent segment disc failure. Thisinvention also address all three pain generators at the lumbar disclevel including the degenerative disc, the impingement of the neuralstructures, and the facet joint.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-30 relate to a lumbar disc prosthesis according to embodimentsof the present invention and FIGS. 31-50 relate to a facet jointreplacement prosthesis according to embodiments of the presentinvention.

FIG. 1 is a side view of a lumbar disc prosthesis according to oneembodiment of the present invention;

FIGS. 2-4 show the prosthesis in FIG. 1 with the upper disc member inextension, flexion and in a neutral position respectively;

FIGS. 5 and 6 show the superior surfaces of the upper members of theleft and right lumbar prosthesis pairs respectively;

FIGS. 7 and 8 show rear views of the left and right lumbar prosthesispairs respectively;

FIGS. 9 and 10 show front views of the left and right lumbar prosthesispairs respectively;

FIGS. 11 and 12 show oblique views of the left and right lumbarprosthesis pairs respectively;

FIGS. 13 and 14 show the superior surfaces of the lower members of theleft and right lumbar prosthesis pairs respectively;

FIGS. 15 and 16 show rear views of the lower members of the left andright lumbar prosthesis pairs respectively;

FIG. 17 is a side view of the lower member of a lumbar prosthesis;

FIGS. 18 and 19 show front views of the lower members of the left andright lumbar prosthesis pairs respectively;

FIGS. 20 and 21 show oblique views of the lower members of the left andright lumbar prosthesis pairs respectively;

FIG. 22 is a side view of an upper member of a lumbar prosthesis pair toillustrate the angulations and geometry of the inferior surface thereof;

FIG. 23 is a front view of the upper member of the lumbar prosthesispair to illustrate the radius in the medial and lateral part of thecurvature of the inferior surface;

FIG. 24 is an oblique view of the upper member of the lumbar prosthesispair to further illustrate the shape of the inferior articulatingsurface thereof;

FIG. 25 shows a perspective view of the inferior surface of the uppermembers of the left and right lumbar prosthesis pairs respectively;

FIGS. 26 a-d illustrates a) a solid inverse representation of the recessportion shape on the inferior surface of the upper member of theprosthesis b) an axial view of the prosthesis c) a side view and d) afront view showing the medial/lateral asymmetry of the prosthesis;

FIG. 27 is a cross section through the upper member of a lumbarprosthesis pair showing the medial lateral curvature of the articulatingsurface;

FIG. 28 show front views of the left and right lumbar prosthesis pairsrespectively in an alternative embodiment with the screws replaced byfin members;

FIGS. 29 a and 29 b illustrate oblique views of the left and rightlumbar prosthesis pairs in FIG. 28 joined together and spaced apartrespectively;

FIGS. 30 a-30 f show a) superior surfaces of the upper members of theleft and right lumbar prosthesis pairs in FIG. 28 b) a side view c) afront view d) a further side view e) inferior surfaces of the lowermembers of the left and right lumbar prosthesis pairs and f) obliqueviews of the pairs;

FIG. 31 is a side view of a facet joint replacement prosthesis accordingto an embodiment of the present invention;

FIGS. 32-36 show a front view, end view, side view, rear view andoblique view respectively of the second or female member of the facetreplacement prosthesis;

FIG. 37 is a cross sectional view of the second or female member of thefacet replacement prosthesis taken along the line marked A-A in FIG. 34;

FIGS. 38-42 show a front view, end view, side view, rear view andoblique view respectively of the first or male member of the facetreplacement prosthesis;

FIG. 43 is a cross sectional view of the first or male member of thefacet replacement prosthesis taken along the line marked A-A in FIG. 40;

FIGS. 44 a-44 d illustrate a side view, front view, perspective viewfrom the rear and perspective view from the front of the facet jointreplacement prosthesis in FIG. 31;

FIGS. 45 a and 45 b illustrate the ability of the male member to movewithin the female member and produce a flexion and extension movement ofthe vertebral body respectively;

FIG. 46 illustrates end views of the facet replacement prosthesisshowing the ability of the male and female components to undergo limitedrelative rotational movement;

FIG. 47 illustrates front views of the facet replacement prosthesisshowing the ability of the male and/or female components to undergo sideto side flexion;

FIGS. 48 a-48 d show a side view, front view, perspective view from therear and perspective view from the front of facet joint prostheses whenstacked respectively;

FIG. 49 is an enlarged view of the ends of the female and male membersof the facet joint prosthesis; and

FIG. 50 is a cross sectional view taken through a pedicle screw attachedto a female member of a facet joint prosthesis.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Lumbar Disc Prosthesis

Referring firstly to FIGS. 1-30, there is illustrated a lumbar discprosthesis 2 which can be inserted into a lumbar disc space via aposterior route as a replacement for a diseased and/or damaged lumbardisc.

The disc prosthesis 2 includes two pairs of disc members, each pairincluding an upper disc member 4, 4′ and a lower disc member 6, 6′.(Useof a reference numeral with ′ thereafter refers to a second or furtherfeature equivalent to the feature indicated by the reference numeralalone. Thus, disc member 4 refers to the first prosthesis pair uppermember and disc member 4′ refers to the second prosthesis pair uppermember). The upper and lower disc members 4, 6; 4′, 6′ of each pairconstitute a left and right disc prosthesis respectively. These discmembers are shaped and dimensioned such that they can be inserted into alumbar disc space either side of the dural sac whilst taking intoaccount the posterior neural anatomy.

Each upper disc member 4, 4′ includes a vertebral endplate contactingsurface or superior surface 8, 8′ and an inferior surface 10, 10′. Eachlower disc member 6, 6′ includes a superior surface 12, 12′ and avertebral endplate contacting surface or inferior surface 14, 14′.

A dome shaped protrusion 16 is formed substantially centrally ofsuperior surface 12 of lower disc member 6. Protrusion 16 is received ina substantially central recess 18 on inferior surface 10 of upper discmember 4 as will be described in more detail below.

Both the superior surface 20 of upper member 4 and the inferior surface22 of lower member 6 are angled to provide the prosthesis with a “leadin” or narrowing tapered feature. This lead in feature allows theprosthesis to enter the posterior disc space which is narrower than theanterior disc space. In addition to the lead in feature which isprovided at the anterior or front end 24 of the prosthesis members, eachprosthesis pair has a lordosis or narrowing taper angle towards theposterior or rear end 26 of the prosthesis members between the inferiorsurface 14 of the lower disc member 6 and superior surface 8 of theupper member 4 of approximately 6 degrees (this angle or any other anglementioned hereinafter is for exemplary purposes and does not limit theinvention in any way), as shown in FIG. 1. This makes the outer surfacesof the disc prosthesis pairs at the posterior and anterior endssubstantially wedge shaped or tapered to allow ease of insertion intothe disc space. The taper or angle of the outer surfaces at theposterior end is in an opposite direction to the taper or angle of theouter surface at the anterior end.

With reference to FIGS. 1-27, the superior surface of upper disc member4 and the inferior surface of lower disc member 6 have attachment meansin the form of screws 28 to allow attachment of the disc prosthesis toadjacent vertebrae when positioned in a patient. Apertures 30 areprovided on the inferior and superior surfaces 10, 12 of the upper andlower disc members 4, 6 respectively of the prosthesis pairs to allowthe insertion of screws 28 through the prosthesis disc members. Thescrews are typically fitted from the posterior end 26 and the screws andinterior walls defining apertures 30 are provided at an acute angle tothe vertical to allow ease of attachment. Apertures 30 and screws 28within each pair diverge outwardly away from each other towards anteriorend 24. The inferior surface on which these apertures are provided onthe upper disc member is angled such that it slopes upwardly towards thesuperior surface of the upper disc member. The superior surface on whichthese apertures are provided on the lower disc member is angled suchthat it slopes downwardly towards the inferior surface of the lower discmember, thereby forming a narrowing taper at the posterior end of thelower disc member. These angled surfaces typically form, at least inpart, the posterior end segments of the inferior and superior surfaces48, 38 of the upper and lower disc members 4, 6 respectively. Thisfeature is to allow ease of insertion of screws or other attachmentmeans to anchor the prosthesis into the vertebra.

With the protrusion 16 on lower member 6 located in recess 18 of uppermember 4 when the prosthesis is assembled, relative movement between theupper and lower members 4, 6 allows the prosthesis to undergo extensionand flexion. The substantially dome shaped protrusion 16 contacts only apart of the recess 18 due to differences in symmetry and geometry. Inthe example illustrated, the upper member 4 can move with respect to thelower member 6 through approximately 10 degrees in a posterior directionto allow extension of the prosthesis, as shown in FIG. 2. Due to thenature of the inferior surface 10 of upper disc member 4, as the uppermember 4 goes into extension there is an increased distance adjacentanterior end 24 between the upper and lower members 4, 6. This resultsin a tightening of the annulus anteriorly, as is seen in physiologicalextension in the disc.

The upper member 4 can also move with respect to lower member 6 throughapproximately 10 degrees in an anterior direction to allow flexion ofthe prosthesis, as shown in FIG. 3. Again, due to the nature of inferiorsurface 10, as upper member goes into flexion there is in an increaseddistance adjacent posterior end 26 between the upper and lower members4, 6. This results in a tightening of the annulus posteriorly and servesas a natural block to further flexion.

Referring to FIGS. 13-21, there are shown more detailed views of lowerdisc prosthesis member 6, 6′. The dome shaped protrusion 16 is locatedin a central or intermediate section of superior surface 12 in theanterior to posterior plane. The anterior and posterior end sections 36,38 either side of the dome section 40, as shown by dotted lines 42, areprovided at an acute angle to the horizontal sloping downwardly fromintermediate section 40 towards ends 24, 26 respectively. The angledsurfaces 36, 38 are typically substantially planar in form. Thisdownwards incline is to accommodate the flexion and extension of theupper disc member 4 without impingement therewith. In the medial andlateral plane, protrusion 16 extends substantially the entire distancebetween the sides of the prosthesis member or from the medial to thelateral edges 32, 34 respectively.

Referring to FIGS. 22-27, there is illustrated more detailed views ofupper disc member 4 showing in particular the curvature and complexgeometry of the inferior surface 10. The surface 10 is divided intothree distinct regions as with the superior surface of lower disc member6; a substantially central or intermediate section 44 and anterior andposterior end sections 46, 48 respectively. Each section typicallyoccupies approximately one third of the inferior surface.

The central section 44 is substantially curved and forms an asymmetricalinverse dome shaped recess 18. The curvature of the recess in the medialhalf (i.e. portion adjacent medial edge 32) of the central sectiondiffers to the curvature of the recess in the lateral half (i.e. portionadjacent the lateral edge 34) of the central section. More specifically,the medial half of the dome has a curvature corresponding to the arc ofa circle having a radius of approximately 15 mm as shown by arrow 50,whereas the lateral half of the dome has a curvature corresponding tothe arc of a circle having a radius of approximately 40 mm, as shown byarrow 52 in FIG. 23. Thus, the curvature of the lateral half of thecentral section corresponds to an arc of a circle having a radius atleast double that of the arc of a circle corresponding to the curvatureof the medial half of the central section. The purpose of this asymmetryin the medial/lateral plane is to allow capture of the “dome” shapedprotrusion 16 of the lower disc member, but still allow some medial andlateral movement of the disc members. This contributes to stability andprevents dislocation of the upper and lower disc members duringmovement. The shorter curvature of the medial half of the centralsection relative to the lateral half helps in the medial and lateralmovement of the two vertebral bodies on the right and left prosthesis.

The anterior and posterior end sections 46, 48 are provided at an acuteangle to the horizontal, typically approximately 12-14 degrees as shownin FIG. 22, and provide an incline sloping downwardly from the centralsection 44 to the anterior and posterior ends 24, 26 of the inferiorsurface respectively. The surface of the anterior and posterior endsections that runs from the central section to the edge of the anteriorand posterior sections, as seen in FIG. 25, is generally planar,although a mild curvature or concavity to the surface can be provided.It is to be noted that the slope of the anterior section 46, 46′ endsbefore the anterior end, thereby leaving a small planar surface 54adjacent anterior end 46, 46′. In the lateral view, the edge of theanterior and posterior surfaces is substantially planar, and does notinclude a radius, so that the distance between the vertebrae increasesin flexion and extension.

The curvature of the central section recess on the anterior to posterioraxis corresponds to an arc of a circle having a radius of approximately17 mm, as shown by arrow 56 in FIG. 22. This is designed so that incombination with the other geometric features of the prosthesis,anterior and posterior movement of the upper disc member is allowed withrespect to the lower disc member of approximately 10 degrees, aspreviously described in relation to FIGS. 2 and 3, even if theprosthesis pairs are not exactly parallel to each other. This geometryis also designed to allow limited sideways (medial/lateral plane) tiltof the upper disc member on the lower disc member, allowing sidewaysmovement of the two disc members on each other, such that the right andthe left prosthesis move in tandem.

The geometry of the inferior surface of the upper disc member is alsodesigned to allow limited rotation of the right or left prosthesispairs. This means that if the upper disc member of the right prosthesispair moves anteriorly, the upper disc member on the left prosthesis pairmoves posteriorly allowing limited rotation of the two vertebral membersto occur.

The aim of the surgical procedure for the disc replacement is to insertthe left and right prosthesis pairs as parallel to each other aspossible within the disc space. However, even if there is medial tilt ofbetween 0-25 degrees between the prosthesis pairs, anterior andposterior movement of the pairs will still be possible and the upper andlower disc members will remain articulated during this movement. Thus,one disc pair is located at one side of the disc space and the otherdisc pair is located at the opposite side of the disc space (i.e in themedial lateral plane).

According to a further embodiment of the present invention, alternativeattachment means can be provided in the form of fin members 58 on thesuperior surface 8 of the upper disc member 4 and on the inferiorsurface 14 of the lower disc member 6, as shown in FIGS. 28-30 f. Finmembers 58 anchor the disc prosthesis to adjacent vertebrae.

Fins 58 are substantially triangular in shape and are providedlongitudinally of the prosthesis (i.e. between the posterior andanterior ends) towards the medial edge 32 of the disc members, so as toavoid the exiting nerve root which goes across the disc laterally. Morespecifically, the fins are located adjacent posterior end 26 and endbefore the lead in feature 20, 22 at the anterior end to avoid theexiting lumbar nerve root above the disc on the lateral side (i.e. theyextend for approximately two-thirds of the disc surface). The fin has anarrowing taper from posterior end 26 towards anterior end 24.

With the disc prosthesis pairs fitted, the upper disc members typicallymove substantially symmetrically on the lower disc members as the uppervertebral body moves forward on the lower vertebral body. The anteriorand posterior translations of these upper disc members are limited by atightening of the anterior and posterior annulus in flexion andextension. This is designed to reflect the physiological process bywhich the anterior and posterior annulus tightens in flexion andextension in a normal lumbar disc.

It is to be noted that the end parts of the lateral side 34 of the discmembers are curved to accommodate the lateral aspect of the disc spacewhich is similarly curved, thereby allowing better anatomical placement.Thus, the lateral side includes an intermediate substantiallystraight/linear/planar surface with the end portions either side thereofcurving inwardly towards the posterior and anterior ends respectively.The medial side 32 of the disc members is substantiallystraight/linear/planar.

Apertures 60 are defined in the posterior end 26 of the upper and lowerdisc members of each prosthesis pair to allow engagement of an insertiontool therewith so that the prosthesis pairs can be inserted into thedisc space. Apertures 60 are typically a spaced distance apart and theapertures on the upper disc member are substantially aligned with theapertures on the lower disc member.

Facet Joint Replacement Prothesis

Referring to FIGS. 31-50, there is illustrated a facet joint replacementprosthesis 102 according to an embodiment of the present invention.Facet joint prosthesis 102 can be used alone, or in combination with thelumbar disc prosthesis described above to form a single unit system. Itis designed to replace the entire facet joint on both the right and theleft side of the vertebrae.

Prosthesis 102 includes a first member or male member 104 and a secondmember or female member 106. Both male and female members 104, 106 aresubstantially elongate in form. Male member 104 has a first end 108 withsecuring means in the form of an aperture 110 defined therein and asecond end 112. End 108 is in the form of a flat or planar plate portion113 and a curved arm portion 114 is provided between this plate portion113 and end 112. Female member 106 has a first end 116 with securingmeans in the form of an aperture 118 defined therein and a second end120. End 116 is in the form of a flat or plate portion 117 and a curvedchannel portion 122 is provided between this plate portion 117 and end120.

The facet prosthesis 102 is inserted by removing the entire existingfacet joint and placing pedicle screws 124 into the vertebral body aboveand below the disc. End 112 of male member 104 is inserted into end 120of channel 122 of female member 106 and the ends of the pedicle screws123 are threaded through apertures 118 and 110 and secured with a nut126. The edge of plate portions 113 and 117 which define apertures 118and 110 are tapered inwardly so as to allow a good fit with a tapered orconical shaped locking nut 126, as shown in FIG. 50. A further spacingor locking nut 127 can also be provided.

Male member 104 has a rear or posterior 128 and a front or anteriorsurface 130. The anterior surface 130 of arm portion 114 is typicallysubstantially concave in shape and the posterior surface 128 of armportion 114 is typically substantially convex in shape. As such, whenmember 104 is fitted to pedicle screw 124 in use, anterior surface 130typically faces the vertebrae to which it is to be attached.

Female member 106 has a rear or posterior surface 132 and a front oranterior surface 134. The anterior surface 134 of channel portion 122 istypically substantially concave in shape and the posterior surface ofchannel portion 122 is typically substantially convex in shape. As such,when member 106 is fitted to pedicel screw 124 in use, anterior surface134 typically faces the vertebrae to which it is to be attached.

Thus, with the female member interconnected to the male member, theprosthesis curves outwardly from the vertebrae and outwardly of theplate portions 117 and 113. Arm portion 114 of male member 104 is freelyslidable or movable in channel portion 122 of female member 106. Thecurvature of the male and female members is substantially the same. Themale member 104 is of slightly smaller dimensions than the interiordimensions of channel portion 122, such that there is a small gaptherebetween to allow some sideways movement, as shown by arrows 150 inFIG. 47, and rotation of the male member in the female member, as shownby arrows 152 in FIG. 46. The male member can also move longitudinallyin the female member to allow flexion and extension of the prosthesisand thus the vertebral body, as shown by arrows 154 in FIGS. 45 a and 45b.

End 120 of channel portion 122 has curved ends 136 and straight sidewalls 138 or side walls of less curvature than said curved ends to forma flattened oval shape, as shown in FIG. 49. Preferably side walls 138form part of an arc, the radius of which is larger than for the arc ofthe curved ends 136. End 112 of arm portion 114 is substantiallycomplementary in shape to end 120 having curved ends 140 and straightside walls 142 or side walls of less curvature than said curved ends.Preferably side walls 142 form part of an arc, the radius of which islarger than for the arc of the curved ends 140. The provision of theshaped ends allows a small degree of rotation of the male component inthe female component.

The anterior surface 134 of channel portion 122 has a slot 144 providedlongitudinally thereof. Slot 144 is of such a width that the channelportion encloses approximately 70% of the male member 104 wheninterconnected therewith and is provided to allow some lateral flexionand/or extension and rotation between the male and female members.

A left and right pair of facet joint prostheses are located between thedisc on each side thereof. It is irrelevant whether the female or themale member is uppermost and thus the position of the members isinterchangeable. In addition, the facet prosthesis can be used at twoadjacent levels, and anchor into pedicle screws, as seen in FIGS. 48a-48 d. A middle pedicle screw 124′ can be used to accommodate two plateportions of the male and/or female members to form a stack. Any numberof members can be attached to a pedicle screw as required.

The prosthesis can be formed from any suitable material, such as forexample, stainless steel, ceramics, titanium, carbide or other suitablemetal alloys. The surface of the prosthesis can be provided slightlyroughened so as to increase bonding of the same with bone and/or one ormore surface coatings can be provided thereon, such as for example,hyroxyapitite or plasma spray.

Thus, it can be seen that in one aspect of the present invention, thetwo pairs of lumbar disc prosthesis and the two pairs of facet jointprosthesis can be used to form a system designed to allow anarthroplasty to be performed through the posterior route, allowingmovement between the vertebral bodies as well as restoring stabilitybetween the two vertebral bodies by allowing normal load transmissionacross the disc, freeing up the neural structures and replacing thefacet joints as well.

1. A lumbar disc prosthesis, said lumbar disc prosthesis including apair of disc members, a first member of said disc pair having avertebral endplate contact surface and a recessed portion on an opposingsurface thereof, a second member of said disc pair having a vertebralendplate contact surface and a protruding portion on an opposing surfacethereof, the protruding portion of the second member engaging in therecessed portion of the first member in use, and wherein the prosthesisincludes a further pair of disc members, said further pair of discmembers also including first and second members.
 2. A prosthesisaccording to claim 1 wherein the two pairs of disc member are mirrorimages of each other.
 3. A prosthesis according to claim 1 wherein thepairs of disc members are inserted via a posterior route into a discspace in the patient.
 4. A prosthesis according to claim 1 wherein eachpair of disc members is independently inserted into the disc space inthe patient and is located on either side of the dural sac.
 5. Aprosthesis according to claim 1 wherein the recessed portion of thefirst member is substantially curved and the curvature of a medial partof said recessed portion is asymmetrical to the curvature of a lateralpart of said recessed portion.
 6. A prosthesis according to claim 5wherein the lateral part of said recessed portion corresponds to an arcof a circle which has a radius greater than that of an arc of a circlecorresponding to the curvature of the medial half of the recessedportion.
 7. A prosthesis according to claim 1 wherein an anterior partof the recessed portion is substantially symmetrical to a posterior partof the recessed portion.
 8. A prosthesis according to claim 1 whereinthe recessed and protrusion portions in each disc member pair areasymmetrical.
 9. A prosthesis according to claim 1 wherein theprotrusion portion in a disc member pair makes contact with only a partof the recessed portion of said disc member pair.
 10. A prosthesisaccording to claim 1 wherein the protrusion portion is symmetrical inthe medial-lateral plane and the anterior-posterior plane but thecurvature in the medial to lateral plane may be different to that in theanterior to posterior plane.
 11. A prosthesis according to claim 1wherein one or both ends of each prosthesis pair have a narrowing tapertowards said end or ends.
 12. A prosthesis according to claim 1 whereinthe vertebral endplate contact surfaces at one or both ends of saidfirst and/or second member is provided at an acute angle to thehorizontal such that the surfaces slopes towards the ends of the discmember(s).
 13. A prosthesis according to claim 12 wherein the angledsurface or surfaces are substantially planar in form.
 14. A prosthesisaccording to claim 12 wherein with the vertebral endplate contactsurfaces provided at an angle at both ends of said first and/or secondmember, the angle of the surface towards an anterior end is in anopposite direction to the angle of the surface towards a posterior end.15. A prosthesis according to claim 14 wherein the anterior end angledsurface is substantially smaller in dimensions that the posterior endangled surface.
 16. A prosthesis according to claim 1 wherein thevertebral endplate contact surface of the first and/or second discmembers are provided with attachment means thereon to allow attachmentof the disc members to an adjacent vertebra in use.
 17. A prosthesisaccording to claim 16 wherein the attachment means includes one or moreapertures thereon for the location of screws or other attachment devicestherewith.
 18. A prosthesis according to claim 16 wherein the attachmentmeans are provided adjacent a posterior end of the first and/or seconddisc members.
 19. A prosthesis according to claim 16 wherein theattachment means includes one or more tapered members protrudingoutwardly of the vertebral endplate contact surface, the taper of saidmember narrowing from a posterior end towards an anterior end of thedisc member.
 20. A prosthesis according to claim 16 wherein theattachment means are provided towards a medial side of the first and/orsecond disc members.
 21. A prosthesis according to claim 1 wherein theinner or opposing surfaces of the first and/or second members in a discpair are divided into at least three sections; a middle section and atleast two end sections, the recessed and protruding portions beingprovided in the middle section of the respective disc members.
 22. Aprosthesis according to claim 21 wherein the depth of the first discmember is less adjacent the middle section or recessed portion comparedto the two end sections thereof.
 23. A prosthesis according to claim 21wherein the boundaries of the middle and end sections are arranged inthe medial to lateral plane of each disc member.
 24. A prosthesisaccording to claim 21 wherein the middle section is locatedsubstantially centrally of said first and/or second disc members.
 25. Aprosthesis according to claim 21 wherein the middle and end sectionseach comprise at least one third of a disc member surface.
 26. Aprosthesis according to claim 21 wherein one or both end sections of theopposing surfaces of the first and/or second disc members are providedat an acute angle to the horizontal.
 27. A prosthesis according to claim26 wherein the angled surface of one or both end sections of said firstand/or second disc members are substantially planar in form.
 28. Aprosthesis according to claim 16 wherein the end sections of theopposing surface of said first disc member are mildly concave in form.29. A prosthesis according to claim 16 wherein when one of the discmembers moves towards an end of the prosthesis in extension or flexion,a gap between the end sections of the disc members increases at anopposite end of the prosthesis.
 30. A prosthesis according to claim 1wherein the vertebral endplate contact surface and opposing surface ofsaid second disc member form a narrowing taper towards one or both endsof said disc member.
 31. A prosthesis according to claim 1 wherein thevertebral end plate contact surface and opposing surface of said firstdisc member form a narrowing taper towards one or both ends of said discmember.
 32. A prosthesis according to claim 1 wherein the protrusionportion extends across substantially the whole of the second disc memberin the medial to lateral plane.
 33. A prosthesis according to claim 1wherein the lateral side of the first and/or second disc members has oneor more curved sections whereas the medial side of the first and/orsecond disc members is substantially straight or planar.
 34. Aprosthesis according to claim 1 wherein one or more apertures areprovided at or adjacent the posterior end of the disc members.
 35. Aprosthesis according to claim 1 wherein said prosthesis is used inconjunction with a facet joint prosthesis.
 36. A facet joint prosthesisaccording to claim 35 wherein a first member is provided for attachmentto a first posterior lumbar disc in use and a second member is providedfor attachment to a second posterior lumbar disc in use, and wherein atleast a part of said first member is telescopically mounted in at leasta part of said second member in use.
 37. A facet joint prosthesisaccording to claim 36 wherein the first and/or second members areprovided with or are associated with securing means for securing themembers to a disc in use.
 38. A facet joint prosthesis according toclaim 37 wherein the securing means includes one or more pedicle screws.39. A facet joint prosthesis according to claim 36 wherein the firstmember includes an elongate arm portion which is movably located in anelongate channel portion on said second member.
 40. A facet jointprosthesis according to claim 39 wherein the arm portion and saidchannel portion are curved in form.
 41. A facet joint prosthesisaccording to claim 39 wherein each of said arm portion and said channelportion communicate with a plate portion.
 42. A facet joint prosthesisaccording to claim 36 wherein a slot is provided longitudinally of saidchannel portion.
 43. A facet joint prosthesis according to claim 42wherein said slot is of such a width to allow approximately 30% of thearm portion to be visible therethrough.
 44. A facet joint prosthesisaccording to claim 36 wherein the arm portion is of slightly smallerdimensions than the interior dimensions of said channel portion, suchthat a small gap is provided therebetween to allow some movement betweensaid arm portion and said channel portion.
 45. A facet joint prosthesisaccording to claim 36 wherein with the arm portion located in thechannel portion, the arm portion can undergo limited rotation, side waysmovement and sliding movement to allow flexion and extension withrespect to said channel portion.
 46. A facet joint prosthesis accordingto claim 36 wherein the end of the arm portion engaging in said channelportion has curved end walls and curved side walls, the curvature ofsaid side walls being less than the curvature of said end walls.
 47. Afacet joint prosthesis according to claim 36 wherein the open end of thechannel portion in which the arm portion engages has curved end wallsand curved side walls, the curvature of said side walls being less thanthe curvature of said end walls.
 48. A facet joint prosthesis accordingto claim 35 wherein a pair of facet joint prosthesis are used for eachdisc.
 49. A facet joint prosthesis according to claim 36 wherein aplurality of first members can be attached to a second member and viceversa to form stacking of said prosthesis.
 50. A prosthesis system, saidsystem including a lumbar disc prosthesis and facet joint prosthesis asdefined in claim
 1. 51. A first disc member for use with a lumbar discprosthesis according to claim
 1. 52. A second disc member for use with alumbar disc prosthesis according to claim
 1. 53. A facet jointprosthesis, said facet joint prosthesis including a first member forattachment to a first posterior lumbar disc in use and a second memberfor attachment to a second posterior lumbar disc in use, and wherein atleast a part of said first member is telescopically mounted in at leasta part of said second member in use.
 54. A prosthesis system, saidsystem including a lumbar disc prosthesis and facet joint prosthesis asdefined in claim
 53. 55. A method of attachment of a lumbar discprosthesis in a patient, said lumbar disc prosthesis including a pair ofdisc members, a first member of said disc pair having a vertebralendplate contact surface and a recessed portion on an opposing surfacethereof, a second member of said disc pair having a vertebral endplatecontact surface and a protruding portion on an opposing surface thereof,the protruding portion of the second member engaging in the recessedportion of the first member in use, the prosthesis including a furtherpair of disc members, said further pair of disc members also includingfirst and second members, said method including the steps inserting eachpair of disc members via a posterior route.
 56. A method of attachmentof a facet joint prosthesis in a patient, said facet joint prosthesisincluding a first member and a second member, at least a part of saidfirst member is telescopically mounted in at least a part of said secondmember in use, said method including attaching a part of said firstmember to one of an upper or lower vertebrae in use posteriorly andattaching a part of said second member to the other of said upper orlower vertebrae in use posteriorly.